Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study

Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

Study Overview

• Status: Terminated
• Conditions: Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth
• Intervention / Treatment: Device: Celtra Duo

Detailed Description

The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
• reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
• Teeth to be vital and asymptomatic prior to treatment
• No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion Criteria:

• Devital or sensitive teeth
• Teeth with prior endodontic treatment of any kind
• Teeth with a history of direct or indirect pulp capping procedures
• Patients with significant untreated dental disease to include periodontitis and rampant caries
• Pregnant or lactating women
• Patients with a history of allergies to any of the materials to be used in the study
• Patients unable to return for the recall appointments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glazed Fired, Calibra Céram; Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement	Device: Celtra Duo; Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
Experimental: Hand Polished, Calibra Universal; Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement	Device: Celtra Duo; Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown Failure	Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.	from delivery of the crown up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown Loss of Retention	Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.	3 years
Tooth Sensitivity	Tooth Sensitivity is evaluated as either "0" if the subject reports that there is NO sensitivity for the tooth with the study crown, or "1" if the subject reports that there IS tooth sensitivity to hot/cold or biting pressure. The better outcome is to have NO tooth sensitivity. The number of teeth with tooth sensitivity are listed below.	3 years
Margin Staining	Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.	from delivery of the crown up to 3 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Dentsply Sirona Inc.
• Investigators: Principal Investigator: Dennis J Fasbinder, DDS, University of Michigan

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: CAD/CAM; Ceramic; Crown
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Tooth Injuries; Dental Caries; Tooth Fractures
• Other Study ID Numbers: HUM00103921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No